Overview
Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose
Status:
Recruiting
Recruiting
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Cornea and Laser Eye InstituteTreatments:
Riboflavin
Criteria
Inclusion Criteria:- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-surgical corneal ectasia
- Contact lens wearers only: removal of contact lens for the required period of 1 week
prior to the screening refraction
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria:
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the
severity grading scheme
- Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by
Pentacam in the eye(s) to be treated
- Previous ocular condition (other than refractive error) in the eye(s) to be treated
that may predispose the eye for future complications, for example: History of corneal
disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome,
corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the
CXL treatment zone
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- Pregnancy (including plan to become pregnant) or lactation during the course of the
study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during
the CXL treatment or other diagnostic tests
- Patients with a current condition that, in the investigator's opinion, would interfere
with or prolong epithelial healing